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N/A N=120 Treatment

Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department

Vascular Access Complication

Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: First Attempt Success Rate — 92 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
AccuCath 2.25" BC Intravascular Catheter (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
C. R. Bard
Primary completion
Jun 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
First Attempt Success Rate
92
PRIMARY
Number of Catheter Attempts Required to Complete Successful PIV Placement
1
SECONDARY
Time to Catheter Placement
2
SECONDARY
Complications
18
SECONDARY
Dwell Time
90.98
SECONDARY
Completion of Therapy
102
SECONDARY
Patient Satisfaction
5
SECONDARY
Patient Satisfaction
5

Summary

Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the emergency department.

Eligibility Criteria

Inclusion Criteria

  • Male or female, age > 18 years old;
  • Capable and willing to give informed consent;
  • English speaking;
  • Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician;
  • Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay;
  • Difficult venous access patient as defined by either 2 failed initial attempts without ultrasound guidance or a history of difficult access plus the inability to directly visualize or palpate a target vein.

Exclusion Criteria

  • Male or female, < 18 years old;
  • Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
  • Previous venous grafts or surgery at the target vessel access site;
  • Subjects with lymphedema or status-post mastectomy on affected side;
  • Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02449798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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